MAUDE Adverse Event Report: COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR, ESOPHAGEAL

Catalog Number	MBL-6-XL-C
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report on premature band deployment.The trigger cord attached to the two-way handle, barrel and two deployed black bands were included in the return.Four (4) bands had deployed and were not included in the return.The loading catheter and the irrigation adapter were also not included in the return.A functional test could not be performed due to the condition of the returned device.A visual examination of the device was performed.The trigger cord was examined and all twelve (12) deployment beads were present.The beads were examined using magnification and found to be correctly filled and had no evidence of excess flash.The length of the trigger cord was measured within tolerance.The trigger cord was intact and not broken.An evaluation of the handle wheel movement was performed and the wheel functioned as intended.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Premature band deployment can occur if the handle is placed in the firing position before the endoscope is in place inside the patient or even while winding the trigger cord.The user is advised not to apply tension to the trigger cord while winding it on the handle to avoid premature deployment of bands.The instructions for use advises the user: ¿with handle in two-way position, slowly rotate handle clockwise to wind trigger cord onto handle spool until it is taut.Note: care must be taken to avoid deploying a band while winding trigger cord." another possible contributing factor to premature band deployment includes allowing the trigger cord to become lodged between the barrel and the distal end of the endoscope.This can restrict trigger cord movement and result in premature band deployment if enough tension is applied to pull the cord free.Prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
In preparation for a procedure, the user selected a cook 6 shooter saeed multi-band ligator.The item, mbl-6-xl-c (g25221) lot w4070139, was defective during a case yesterday in our operating room (or).I was told that the bands kept falling off and not staying on the camera.Additional information was received on 10-july-2018: the bands prematurely deployed.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: 6 SHOOTER SAEED MULTI-BAND LIGATOR
• Common Device Name: MND, LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7710525
• Report Number: 1037905-2018-00326
• Device Sequence Number: 10963993
• Product Code: MND
• UDI-Device Identifier: 00827002252219
• UDI-Public: (01)00827002252219(17)190516(10)W4070139
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2019
• Device Catalogue Number: MBL-6-XL-C
• Device Lot Number: W4070139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS CF-HQ190L COLONOSCOPE